(Contract) Combination Product - Principal Product Development Engineer/Scientist

Kymanox • Morrisville, NC

68d

About The Position

The Kymanox Product Development & Commercialization team is seeking an experienced (Contract) Principal Product Development Engineer or Scientist with a strong technical and/or operations backgrounds in the pharmaceutical (combination product), biotechnology or medical device industries. This role leverages expertise in technical leadership and cross-functional management to advance, de-risk, and deliver successful outcomes for clients’ medical device and combination product development programs.

Requirements

• Advanced degree in natural sciences (Chemistry, Biology, or similar) or engineering (Chemical, Biomedical, or Mechanical Engineering), or related technical discipline from an accredited institution.
• Minimum 15 years' experience in product development and/or manufacturing in the pharmaceutical (combination product), biotechnology, diagnostic, and/or medical device sectors.
• Leadership of complex, multi-disciplinary development programs, pharmaceutical (combination product) development, in vitro diagnostic development, clinical development, or electromechanical systems development is desirable.
• Experience working at startup companies or small biotech/pharma/med device companies and familiarity with government and private sector funding mechanisms is highly favorable.
• Experience working in professional services is favorable.

Nice To Haves

• Industry certificates in project management (e.g., PMP, CAPM), six-sigma, quality, or regulatory affairs preferred but not required.
• Management of direct reports is not in scope of this role at the time of hire, but organizational growth may allow for the role to expand to managerial responsibility of 1-5 direct reports.

Responsibilities

• Representing Kymanox to clients as a subject matter expert and thought leader.
• Providing technical leadership and direction to internal and external project teams.
• Maintaining conformance to internal and client quality management systems.
• Adhering to regulatory standards and promoting a positive compliance culture.
• Providing mentorship to junior staff.
• Evaluate client technical documentation and strategy to provide clear, actionable recommendations for product design, development, and commercialization activities.
• Conduct competitive landscape assessments and market analyses for delivery devices, contract organizations, and novel technologies.
• Prepare detailed project plans, schedules, and overall development strategy.
• Management of technically complex, multi-year development programs.
• Oversee the creation of technical documentation supporting design controls, manufacturing processes, and regulatory submissions.
• Lead the preparation of risk management file documentation.
• Oversee phase-appropriate client testing activities, including combination product and medical device design verification and human factors testing.
• Direct design verification and the associated test method development and validation activities.
• Expert-level statistical analysis of development and production data, strong preference for experience in reliability.
• Contract Manufacturing Organization (CMO) evaluation, due diligence, and selection on behalf of clients.
• Support process development, improvement, and troubleshooting.
• Engage with external partners to facilitate tech transfer.
• Provide technical support for regulatory submission preparation and review.
• Serve as an independent reviewer for client design review meetings throughout the product development process.

Benefits

• Opportunity for learning and career advancement.
• Dynamic and fulfilling team environment.
• Work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry.

What This Job Offers

• Career Level: Senior
• Education Level: Master's degree
• Number of Employees: 251-500 employees